Memoranda

On June 9, 2011, the Food and Drug Administration (FDA or the Agency) posted on its home page a Draft Guidance on Considering Whether an FDA-Regulated Product Involves Application of Nanotechnology. The Agency states that this document is the first step in providing regulatory clarity about the use of nanomaterials in FDA-regulated products and other more product-specific guidance documents are likely to follow. Specifically, the Draft Guidance is "intended to help industry and others identify...

On June 9, 2011, the Office of Science and Technology Policy (OSTP) announced that the White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) has developed a set of principles specific to the regulation and oversight of applications of nanotechnology. The principles are intended to guide the development and implementation of policies, as described in the title "U.S. Decision-making Concerning Regulation and Oversight of Nanotechnology and Nanomaterials" that occur at...

On June 6, 2011, the California Court of Appeal for the First Appellate District affirmed the 2009 decision by the Alameda County Superior Court upholding the Office of Environmental Health Hazard Assessment's (OEHHA) use of the Labor Code mechanism to add chemicals to Proposition 65. California Chamber of Commerce v. Schwarzenegger (Div. 1, No. A125493). This effectively means that the so-called Labor Code mechanism is a viable listing mechanism for Proposition 65 purposes....

Under the revised notification process published this month by Japan's Ministry of Economy, Trade, and Industry (METI), companies exporting to Japan will be better able to protect confidential business information (CBI). Previously, only Japanese entities could notify information on the required substances. The new notification process provides that, if a notifier (manufacturer or importer in Japan) has "extreme difficulties in identifying a certain chemical substance or its concentration rate...

Three Subcommittees of the Green Ribbon Science Panel (Panel) have scheduled several teleconferences between May 31 and June 16, 2011, to discuss potential revisions to the California Department of Toxic Substances Control's (DTSC) Safer Consumer Product Alternatives (SCPA) regulations, as required by AB 1879. These teleconferences are open to the public and comments may be provided. The Panel had previously convened three Subcommittees to discuss issues related to chemical...

As of June 1, 2011, notifications for substances of very high concern (SVHC) identified on the Candidate List before December 1, 2010, contained in articles must be performed. The current Candidate List is available online. Thirty-eight substances are impacted by the June 1, 2011, notification deadline with an additional eight substances to be notified by June 15, 2011. The European Chemicals Agency (ECHA) conducted a webinar...

The Office of the U.S. Trade Representative (USTR) and the Office of Management and Budget's (OMB) Office of Information and Regulatory Affairs (OIRA) issued a May 19, 2011, memorandum to U.S. departments and agencies to highlight the importance of regulatory transparency and openness to promoting international trade. The memorandum is important as it telegraphs the growing importance of trade considerations in domestic regulatory issues, and the Administration's renewed emphasis on the...

According to a Federal Register notice scheduled for publication in the May 11, 2011, Federal Register, the U.S. Environmental Protection Agency (EPA) is amending the Toxic Substances Control Act (TSCA) Section 8(a) Inventory Update Reporting (IUR) regulations by suspending the next IUR submission period, which would otherwise run from June 1, 2011, to September 30, 2011. The IUR requires manufacturers, including...

On May 6, 2011, the U.S. Environmental Protection Agency (EPA) promulgated a final significant new use rule (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the chemical substance identified generically as multi-walled carbon nanotubes (MWCNT), which was the subject of premanufacture notice (PMN) P-08-199. Under the final SNUR, persons intending to manufacture, import, or process MWCNT for a use that is designated as a significant new use by the final rule must notify...

In an important and little noticed May 3, 2011, Federal Register notice, the U.S. Department of Commerce International Trade Administration (ITA) requested public comments concerning regulatory cooperation between the U.S. and the European Union (EU) that would help eliminate or reduce unnecessary divergences in regulation and in standards used in regulation that impede U.S. exports. Of critical importance, the ITA plainly recognizes and acknowledges that the main impediments...

EPA states: "The Office of Pesticide Programs (OPP) initiated and recently completed an internal review of the use of conditional registrations. The review looked at the variability in the use of the term "conditional registration" in the program, how the internal computer coding associated with conditional registrations has been applied, the status of actions that have been characterized as conditional registrations, and the potential for improvements and clarifications." EPA begins by...

MAY 9, 2011 -- SAVE THE DATE Bergeson & Campbell, P.C. (B&C), B&C Consortia Management, L.L.C. (BCCM), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that B&C will host a webinar to discuss Senator Frank Lautenberg's (D-NJ) recently reintroduced bill to amend the Toxic Substances Control Act (TSCA), the Safe Chemicals Act of 2011, on Monday, May 9, 2011, from 1:00 p.m. to 3:00 p.m. (EDT). This...

On April 14, 2011, Senator Frank R. Lautenberg (D-NJ) introduced the Safe Chemicals Act of 2011, which is intended to modernize the Toxic Substances Control Act (TSCA) to require chemical companies to demonstrate the safety of industrial chemicals and the U.S. Environmental Protection Agency (EPA) to evaluate safety based on the best available science. The bill is co-sponsored by Senators Amy Klobuchar (D-MN), Charles Schumer (D-NY), and Barbara Boxer (D-CA). Lautenberg previously introduced...

The U.S. Environmental Protection Agency (EPA) released on April 13, 2011, chemical action plans for methylene diphenyl diisocyanate (MDI), toluene diisocyanate (TDI), and related compounds. According to EPA, Americans may be exposed to these chemicals when they are used in certain applications, such as spray foam insulation, sealing concrete, or finishing floors. EPA states that diisocyanates are used to make polyurethane polymers. Most polyurethane products, such as foam mattresses or bowling...

The European Chemicals Agency (ECHA) announced on April 13, 2011, that it has updated REACH-IT to allow the submission of notifications for substances in articles. Beginning June 1, 2011, companies must notify to ECHA substances present in articles they produce or import that were included on the substances of very high concern (SVHC) Candidate List before December 1, 2010, if both of the following conditions are met: The SVHC is present in those articles at a volume of...

Three Subcommittees of the Green Ribbon Science Panel (Panel) have scheduled several teleconferences between April 4 and April 19, 2011, to discuss potential revisions to the California Department of Toxic Substances Control's (DTSC) Safer Consumer Product Alternatives (SCPA) regulations. These teleconferences are open to the public and comments may be provided. The three Subcommittees and the scheduled teleconferences are as follows: Chemical Identification and...

On April 1, 2011, the European Chemicals Agency (ECHA) announced the availability of an update to the Guidance on Requirements for Substances in Articles. The update replaces the previous Guidance. Beginning June 1, 2011, companies must notify to ECHA substances present in articles they produce or import that were included on the substances of very high concern (SVHC) Candidate List before December 1, 2010, if both of the following conditions are...

Two of the trade associations named as negotiators by the U.S. Food and Drug Administration (FDA) regarding its proposal for the imposition of generic drug user fees have filed comments regarding the proposal that may frame their negotiating posture with the Agency going forward. The Society of Chemical Manufacturers and Affiliates' (SOCMA) Bulk Pharmaceutical Task Force and the European Chemical Industry Council's (CEFIC) Fine Chemicals Group urged FDA to impose a registration fee on each...

On March 29, 2011, the U.S. Senate Committee on Environment and Public Works held a hearing entitled "Oversight Hearing on Disease Clusters and Environmental Health." Committee Chair Barbara Boxer (D-CA) and Senator Mike Crapo (R-ID), Ranking Member of the Superfund, Toxics, and Environmental Health Subcommittee, introduced the Strengthening Protections for Children and Communities from Disease Clusters Act (S. 76), also known as Trevor's Law, on January 25, 2011. The bill would require the U.S....

On March 30 and 31, 2011, the Center for Food Safety and Applied Nutrition (CFSAN) of the U.S. Food and Drug Administration (FDA) will hold a Food Advisory Committee meeting on the possible link between synthetic dyes in food products and behavioral issues in children, such as attention deficit hyperactivity disorder (ADHD). Members of the Food Advisory Committee have been charged to "consider available relevant data on the possible association between consumption of...